BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, announces the initiation of Loramyc®/Oravig® Phase III clinical trial for the treatment of oropharyngeal candidiasis by its Japanese partner Sosei. This is the final step before registration of the drug by Japanese authorities.
In May 2011, BioAlliance Pharma signed a licensing agreement with Sosei Co. Ltd. (a wholly owned subsidiary of Sosei Group Corporation – TSE Mothers Index: 4565) for the conduct of development program and commercialization rights in Japan for Loramyc®/Oravig® (miconazole Lauriad®) muco-adhesive buccal tablet.
As traditionally required by Japanese authorities, a complementary development plan driven by Sosei has been initiated to complete the registration dossier and meet Japanese regulatory requirements. Following the successful phase I clinical trial finalized in July 2012, Sosei is now starting the final step of development with the phase III open-label, randomised trial versus miconazole gel. This study is anticipated to last 12 to 18 months.
“Loramyc®/Oravig® represents a true innovation in the treatment of oropharyngeal candidiasis as compared with available treatments and is expected to improve patients’ compliance and quality of life”, comments Shinichi Tamura, CEO of Sosei Group Corporation. “The initiation of this phase III trial is a key step for us, not only in the development plan of the product in Japan but also in our discussions with potential partners for commercialization once the product is approved”.
“We are very pleased with this new step taken by our partner Sosei in Japan, which should lead them to the final stage of registration in the coming months. From there, commercialization of Loramyc® should then start in one of the major Asian markets that is Japan”, adds Judith Greciet, CEO of BioAlliance Pharma.